A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease.

May 29, 2024 updated by: Dr. Lang Hung Hin, Brian, The University of Hong Kong

There have been previous reports of using High-intensity focused ultrasound (HIFU) as a feasible thermal ablative treatment for relapsed Graves' disease. In recent years, radiofrequency ablation (RFA) has become another promising alternative for thermal ablation of benign thyroid nodules. RFA has the advantage of avoiding a surgical scar, organ preservation and being an ambulatory procedure. It utilizes a small caliber radiofrequency electrode, which is inserted into the thyroid gland percutaneously. The active tip of the RF electrode would induce frictional heat in the surrounding tissue, causing a thermal ablative effect. The direct application of energy of RFA to tissue is different from that in HIFU, in which energy is transmitted through the skin of the participants from the transducer.

Studies of follow-up after RFA of Graves' disease have not been published. Given the previous successful experience with HIFU, the investigators would like to explore the feasibility, safety and efficacy of RFA as an alternative thermal ablation option for relapsed Graves' disease. Thus, the purpose of this prospective study is to assess the efficacy and safety of US-guided RFA for the treatment of relapsed Graves' disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (a) age older than 18 years,
  • (b) relapsed Graves' disease despite an adequate ATD treatment for 18 months or more and
  • (c) absence of vocal cord immobility.

Exclusion Criteria:

  • (a) patients who prefer or indicated for surgery,
  • (b) head and/or neck disease preventing hyperextension of the neck,
  • (c) history of thyroid cancer or other malignant tumors in the neck region,
  • (d) history of neck irradiation,
  • (e) moderate to severe Graves' ophthalmopatty,
  • (f) large compressive goiter
  • (g) pregnancy or lactation, and
  • (h) any contraindication related to intravenous moderate sedation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA treatment
Procedure: Radiofrequency ablation treatment
RFA is used to ablate the entire thyroid gland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term disease remission rate after a single course of RFA
Time Frame: 12 months
Graves' disease remission rate after a single course of RFA
12 months
Mid term remission rate after a single course of RFA
Time Frame: 24 months and 36 months
Graves' disease remission after a single course of RFA
24 months and 36 months
Complication rates
Time Frame: 1 month
To measure the complication rates after RFA
1 month
Change in Quality of life
Time Frame: 24 months, 36 months
To examine the change in qualitfy of life with SF-12 scores in post-treatment from baseline to 24 months and 36 months
24 months, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Matrix, Man Him Fung, MBBS, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 22-504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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